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Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04966130
Collaborator
First Affiliated Hospital, Sun Yat-Sen University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)
96
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    96 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Aug 31, 2022
    Anticipated Study Completion Date :
    Aug 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Day-time continence rate [1 year]

    2. Night-time continence rate [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:

    1. Patients with pathologically confirmed bladder cancer

    2. Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder

    3. Complete perioperative clinical data

    Exclusion Criteria:

    1. Patients diagnosed with distant metastasis

    2. Patients who had urinary incontinence before surgery

    3. Patients with unavailable follow-up data

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • First Affiliated Hospital, Sun Yat-Sen University
    • Third Affiliated Hospital, Sun Yat-Sen University

    Investigators

    • Principal Investigator: Jian Huang, MD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT04966130
    Other Study ID Numbers:
    • SysMU-RARC1
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    muscle-invasive bladder cancer
    robot-assisted radical cystectomy
    urinary indwelling time
    continence
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jul 19, 2021